Bypass sheath

Abstract

An introducer sheath for use in delivering a device includes a proximal portion opposite a distal portion, a body portion extending between the proximal and distal portions, at least one bypass opening, and at least one plug, the body portion defining an introducer sheath lumen configured to receive at least one device, the at least one bypass opening being disposed in the proximal portion of the introducer sheath such that the bypass opening extends from an exterior of the introducer sheath to the lumen of the introducer sheath, and the at least one plug being disposed within the lumen of the introducer sheath and configured to inhibit blood flow into the lumen proximal to the plug.

Description

Technical Field

[0001] The present disclosure relates to the field of introducer sheaths for use in the delivery of percutaneous devices. Specifically, the present disclosure relates to bypass sheaths for use in the intravascular delivery of percutaneous devices.

Background Art

[0002] In various procedures, such as procedures for delivering percutaneous medical devices, an introducer sheath is introduced into a patient's blood vessel, such as the femoral artery, and a medical device inserted through the blood vessel is inserted into the introducer sheath and introduced into the blood vessel. To ensure sufficient volume for introducing the device, the introducer sheath may have the same or substantially the same diameter as the blood vessel. Therefore, while the introducer sheath is positioned within the artery, the introducer sheath may substantially reduce or essentially block blood flow through the blood vessel, which can have various harmful effects on the patient.

Summary of the Invention

[0003] In Example 1, an introducer sheath for use in the delivery of a device includes a proximal portion opposite the distal portion and a body portion extending between the proximal portion and the distal portion, the body portion defining a lumen of the introducer sheath configured to receive at least one device, at least one bypass opening disposed in the proximal portion of the introducer sheath and extending from outside the introducer sheath to the lumen of the introducer sheath, and at least one plug disposed within the lumen of the introducer sheath and configured to inhibit blood flow into the lumen proximal to the plug.

[0004] In Example 2, the introducer sheath of Example 1 further includes the at least one bypass opening comprising a plurality of bypass openings located in the proximal portion of the introducer sheath.

[0005] In Example 3, the introducer sheath of Example 1 further includes the fact that the at least one plug is positioned in a proximal direction to the at least one bypass opening and directly adjacent to the at least one bypass opening.

[0006] In Example 4, the introducer sheath of Example 2 further includes the fact that the at least one plug is positioned directly adjacent to the nearest bypass opening among the plurality of bypass openings.

[0007] In Example 5, the introducer sheath of Example 1 further includes the fact that at least one of the plugs is made of silicone. In Example 6, the introducer sheath of Example 1 further includes that at least one of the plugs has a radiopaque coating.

[0008] In Example 7, the introducer sheath of Example 1 further includes the fact that at least one of the plugs is made of a radiopaque material. In Example 8, the introducer sheath of Example 1 further includes the fact that the at least one bypass opening is lined with a radiopaque material.

[0009] In Example 9, the introducer sheath of Example 1 further includes that the at least one plug has a central opening for a seal engagement with a catheter placed inside the introducer sheath.

[0010] In Example 10, the introducer sheath of Example 9 further includes the central opening being composed of multiple slits. In Example 11, a method for delivering a device to a patient includes inserting an introducer sheath into the patient's blood vessel, the introducer sheath comprising a proximal portion opposite a distal portion, a main body portion extending between the proximal and distal portions and defining a lumen, and at least one bypass opening located in the proximal portion of the introducer sheath. The method further includes inserting the device into the introducer sheath, advancing the device to a target location in the patient, inserting a plug into the introducer sheath, the introducer sheath being positioned such that the plug is adjacent to and proximal to the at least one bypass opening, thereby blocking blood flow to the lumen proximal to the plug.

[0011] In Example 12, the method of Example 11 further includes removing the plug from the introducer sheath and removing the transcutaneous circulatory support device through the introducer sheath.

[0012] In Example 13, the method of Example 11 further includes the fact that the at least one bypass opening comprises a plurality of bypass openings, and the plug is positioned near the nearest bypass opening among the plurality of bypass openings.

[0013] In Example 14, the method of Example 11 further includes the fact that the at least one plug has a central opening for a seal engagement with a catheter placed within the introducer sheath.

[0014] In Example 15, the method of Example 14 further includes the fact that the central opening is composed of a plurality of slits. Example 16 provides an introducer sheath for use in the delivery of a transdermal device, the introducer sheath comprising: a proximal portion opposite to a distal portion; a main body portion extending between the proximal and distal portions, the main body portion defining a lumen of the introducer sheath configured to receive at least one transdermal device; at least one bypass opening located in the proximal portion of the introducer sheath, the at least one bypass opening extending from outside the introducer sheath to the lumen of the introducer sheath; and at least one plug located within the lumen of the introducer sheath, the at least one plug configured to restrict blood flow to the lumen proximal to the plug.

[0015] In Example 17, the introducer sheath of Example 16 further includes the at least one bypass opening comprising a plurality of bypass openings located in the proximal portion of the introducer sheath.

[0016] In Example 18, the introducer sheath of Example 16 further includes the fact that the at least one plug is positioned in a proximal direction to the at least one bypass opening and directly adjacent to the at least one bypass opening.

[0017] In Example 19, the introducer sheath of Example 17 further includes the fact that the at least one plug is positioned directly adjacent to the most proximal bypass opening among the plurality of bypass openings.

[0018] In Example 20, the introducer sheath of Example 16 further includes the fact that at least one of the plugs is made of silicone. In Example 21, the introducer sheath of Example 16 further includes that at least one of the plugs has a radiopaque coating.

[0019] In Example 22, the introducer sheath of Example 16 further includes the fact that at least one of the plugs is made of a radiopaque material. In Example 23, the introducer sheath of Example 16 further includes the fact that the at least one bypass opening is lined with a radiopaque material.

[0020] In Example 24, the introducer sheath of Example 16 further includes that the at least one plug has a central opening for a seal engagement with a catheter placed inside the introducer sheath.

[0021] In Example 25, the introducer sheath of Example 24 further includes the central opening being composed of multiple slits. Example 26 provides a transdermal device delivery system for delivering a transdermal device, comprising a transdermal device having an impeller housing supporting an impeller and a motor configured to rotate the impeller. The system further comprises an introducer sheath for housing the transdermal device, the introducer sheath having a proximal portion, a distal portion, and a body portion extending between the proximal and distal portions, the body portion defining a lumen, the proximal portion including at least one bypass opening extending from outside the introducer sheath to the lumen of the introducer sheath, and the introducer sheath further comprises a plug, the plug being positioned within the lumen and proximal to the at least one bypass opening of the introducer sheath to block the flow of blood to the lumen proximal to the plug.

[0022] In Example 27, the system of Example 26 further includes the fact that the at least one bypass opening is lined with a radiopaque material. In Example 28, the system of Example 26 further includes the fact that the plug is made of a radiopaque material.

[0023] In Example 29, the system of Example 26 further includes that the at least one bypass opening includes a plurality of bypass openings. In Example 30, the system of Example 26 further includes that the at least one bypass opening includes a plurality of bypass openings.

[0024] In Example 31, the system of Example 26 further includes that the plug includes a central opening configured to receive a catheter disposed within the introducer sheath.

[0025] In Example 32, the system of Example 26 further includes that the plug includes a central opening configured by a slit. In Example 33, a method of delivering a percutaneous device to a patient includes inserting an introducer sheath into a blood vessel of the patient, the introducer sheath including a proximal portion opposite a distal portion, a body portion extending between the proximal portion and the distal portion, the body portion defining a lumen, and at least one bypass opening disposed at the proximal portion of the introducer sheath. The method further includes inserting the percutaneous device into the introducer sheath, advancing the device to a target location of the patient, and inserting a plug into the introducer sheath, the introducer sheath being disposed such that the plug is adjacent to and proximal to the at least one bypass opening, and blocking blood flow into the lumen proximal to the plug.

[0026] In Example 34, the method of Example 33 further includes removing the plug from the introducer sheath and removing the percutaneous circulatory assist device through the introducer sheath.

[0027] In Example 35, the method of Example 33 further includes that the at least one bypass opening includes a plurality of bypass openings, and the plug is disposed proximal to the most proximal bypass opening of the plurality of bypass openings.

[0028] Although several embodiments are disclosed, further embodiments of the present invention will become apparent to those skilled in the art from the following detailed description illustrating exemplary embodiments of the invention. Therefore, the drawings and detailed description are considered to be illustrative and not restrictive. [Brief explanation of the drawing]

[0029] [Figure 1] A side view of an introducer sheath after insertion into a blood vessel, according to an embodiment of the present invention, is shown. [Figure 2] Figure 1 shows a side cross-sectional view of the introducer sheath after it has been inserted into a blood vessel, according to an embodiment of the present invention. [Figure 3] An additional side cross-sectional view of a modified example of the introducer sheath of Figure 1 after insertion into a blood vessel, according to an embodiment of the present disclosure, is shown. [Figure 4A] Figure 1 shows a top cross-sectional view of an embodiment of a plug for an introducer sheath according to an embodiment of the present disclosure. [Figure 4B] Figure 4A shows a top cross-sectional view of a variation of the plug for the introducer sheath according to an embodiment of the present disclosure. [Figure 5] Figure 1 shows a lateral cross-sectional view illustrating the introducer sheath receiving the percutaneous circulatory support device and being inserted into a blood vessel. [Figure 6] A method for deploying a delivery device through the introducer sheath shown in Figure 1, according to embodiments of this disclosure, is shown. [Modes for carrying out the invention]

[0030] Detailed explanation Various modifications and additions can be made to the exemplary embodiments described without departing from the scope of the present invention. For example, while the embodiments described above refer to certain features, the scope of the present invention also includes embodiments having different combinations of features, and embodiments that do not include all of the features described above.

[0031] Figure 1 shows a lateral cross-sectional view of a blood vessel V, in which an introducer sheath 100, also called a bypass sheath 100, is inserted at least partially into the blood vessel V. The introducer sheath 100 includes an outer portion 102 located outside the blood vessel V and an inner portion 104 located inside the blood vessel V or circumferentially enclosed by the blood vessel V. Specifically, referring to the inner portion 104 of the introducer sheath 100, the inner portion 104 includes a proximal portion 106 and a distal portion 108 opposite the proximal portion 106. The introducer sheath 100 includes a proximal opening 107 adjacent to the proximal portion 106 and a distal opening 109 adjacent to the distal portion 108. The main body 110 of the introducer sheath 100 extends between the proximal portion 106 and the distal portion 108, and the main body 110 defines the lumen 112 of the introducer sheath 100. The introducer sheath 100 may be formed from various polymer or metallic materials. In further embodiments, the introducer sheath 100 may include an additional surface coating. The surface coating may include, but is not limited to, silicone, PET, or other applicable polymers. The hub 60 (Figure 5) is typically included in the proximal opening 107. The hub 60 may include a hemostatic valve (not shown) to prevent blood from leaking from the introducer sheath during use.

[0032] In the exemplary embodiment shown in Figure 1, the lumen 112 is cylindrical, but various other configurations can be incorporated. Furthermore, the main body 110 of the introducer sheath 100 has an inner diameter D1i and an outer diameter D1o that define the lumen 112. The blood vessel V is defined by an inner diameter D2i and an outer diameter D2o. In some embodiments, the outer diameter D1o is slightly smaller than the inner diameter D2i of the blood vessel V. For example, the outer diameter D1o may be 95% of the value of the inner diameter D2i of the blood vessel V. In various other embodiments, the outer diameter D1o may be 96% to 99% of the inner diameter D2i of the blood vessel V. The inner diameter D1i and outer diameter D1o of the introducer sheath 100 and the lumen 112 can be configured in such a way that the device can pass through the introducer sheath 100, which will be further explained with reference to Figures 5-6. In this way, the gap between the outer diameter D1o of the introducer sheath 100 and the inner diameter D2i of the blood vessel V is narrowed. Therefore, blood flow between the introducer sheath 100 and blood vessel V may be minimized or substantially blocked. This can prevent blood from flowing properly to other parts of the body, potentially causing various complications in the patient. To maintain blood flow, at least one bypass opening can be provided within the introducer sheath 100, as further described herein.

[0033] Continuing to refer to the introducer sheath 100 in Figure 1, the proximal portion 106 includes at least one bypass opening 114 that penetrates the main body portion 110. In other words, at least one bypass opening 114 extends from outside the main body portion 110 to the lumen 112 of the introducer sheath 100. In the exemplary embodiment of Figure 2, the introducer sheath 100 includes a plurality of bypass openings, more specifically, a first bypass opening 114a, a second bypass opening 114b, and a third bypass opening 114c. The first bypass opening 114a is the most proximal bypass opening of the proximal portion 106, and the third bypass opening 114c is the most distal bypass opening of the proximal portion 106. Although illustrated as three bypass openings, the plurality of bypass openings can include any number of bypass openings. For example, the plurality of bypass openings may include four, five, six, or more bypass openings. Furthermore, the distribution and arrangement of the multiple bypass openings may differ from the examples presented herein. For example, the multiple bypass openings may be aligned with each other horizontally or vertically. The multiple bypass openings may be densely packed with each other, and / or may be randomly arranged along the main body 110. Furthermore, the multiple bypass openings may be aligned so that the bypass openings 114 align with anatomical features such as branched vessels. The multiple bypass openings may vary in size, position, and / or shape to optimize blood flow through the introducer sheath 100.

[0034] The configuration of the introducer sheath 100 and the bypass opening 114 allows blood to flow through the introducer sheath 100, thereby increasing blood flow through the blood vessel V compared to a conventional introducer sheath. In a conventional introducer sheath without a bypass opening, the blood flowing into the introducer sheath is substantially inhibited from passing through the introducer sheath within the blood vessel. Therefore, at the location of the conventional introducer sheath, blood flow within the blood vessel may be essentially blocked. In contrast, as described herein, blood flowing into the distal portion 108 of the introducer sheath 100 can exit at the proximal portion 106 of the introducer sheath 100 because at least one bypass opening 114 is present. This reduces the possibility of blood flowing from the distal portion 108 flowing through the introducer sheath 100 and returning to the blood vessel V through the bypass opening 114, thereby reducing the possibility of blood flow being stopped within the introducer sheath 100. Such an arrangement also contributes to the continuation of blood flow through the introducer sheath 100 and into the blood vessel V, which may be particularly advantageous when the outer diameter D1o of the introducer sheath 100 is slightly smaller than the inner diameter D2i of the blood vessel V. As mentioned above, in these examples, the space for blood flow between the introducer sheath 100 and the blood vessel V is very small or nonexistent.

[0035] In some embodiments, it is advantageous to incorporate a plug within the introducer sheath 100 to reduce the possibility of blood stagnating and accumulating within the introducer sheath 100 in portions near at least one bypass opening. Specifically, as further described with reference to Figures 4 and 5, the plug may be used after the transcutaneous circulation assist device has been delivered through the introducer sheath 100. For example, Figure 3 shows the introducer sheath 100 of Figure 1 with at least one additional plug within the introducer sheath 100. Specifically, the introducer sheath 100 includes a plug 120. The plug 120 is shown to be positioned immediately proximal to a plurality of bypass openings and adjacent to the most proximal bypass opening 114a of the introducer sheath 100. In this way, blood flows proximal through the introducer sheath 100, first entering the distal part 108 of the introducer sheath 100, and then exiting the sheath 100 through the multiple bypass openings 114a-c in the proximal part 106. Since the plug 120 is positioned proximal to the multiple bypass openings 114a-c, it prevents or inhibits blood from flowing through the introducer sheath 100 and into a portion of the lumen 112 of the introducer sheath 100 proximal to the multiple bypass openings 114, thus preventing blood from exiting the introducer sheath 100. Therefore, the accumulation of blood in the introducer sheath 100 proximal to the multiple bypass openings 114a-c is significantly reduced.

[0036] The plug 120 may have a cylindrical shape with one or more bypass openings for accommodating a catheter 170 (Figure 5) or various other tools inserted into the introducer sheath 100. In these embodiments, the plug 120 can be made to ensure that blood flow is reliably blocked by forming a fluid seal between the plug 120 and the catheter 170 and / or tool, and between the plug 120 and the introducer sheath 100. For example, as shown in Figures 4A-5, the central opening of the plug 120 can accommodate the catheter 170 (Figure 5) of the percutaneous circulatory support device 130. The opening of the plug 120 can take various forms, such as a slot opening, a cross slit, or other configurations that allow the plug 120 to connect to the catheter 170 without accessing the ends of the catheter 170. For example, Figure 4A shows a circular plug 120 having a circular opening 121 in the center of the plug 120. When in use, the circular opening 121 is set to a size that seals and engages with the catheter 170 when placed on the catheter 170. Figure 4B shows a variation of the plug, specifically plug 120', which is generally circular and has a cross slit 121' in the center of plug 120', thereby allowing plug 120' to be placed on catheter 170 to form a fluid seal between catheter 170, plug 120, and introducer sheath 100. However, various other configurations of the openings of plugs 120, 120' can be incorporated, and the exemplary embodiments presented here are presented as examples only.

[0037] Furthermore, it may be beneficial for the physician to mark the introducer sheath 100 to indicate the location of the introducer sheath 100 and the multiple bypass openings 114a-c. For example, referring to Figure 2, each of the multiple bypass openings 114a-c may have an outer lining (or circumferential lining) 116 made of radiopaque material. This provides the additional advantage that the physician can detect the location of the multiple bypass openings 114a-c, and thus the location of the inner portion 104 of the introducer sheath 100, when the introducer sheath 100 is placed in the patient's blood vessel V. In further embodiments, the plug 120 may be made of a material including but not limited to silicone. In these embodiments, the plug 120 may have a radiopaque coating so that the physician can detect the location of the plug 120 within the inner portion 104. In other embodiments, the plug 120 may be formed entirely of a radiopaque material. Therefore, the location of either the multiple bypass openings 114a-c or the plug 120 can be detected using imaging tests such as ultrasound, X-ray, and / or angiography. For example, radiopaque material may be selected so that the multiple bypass openings 114a-114c can be identified through the use of these various tests. This allows the physician to confirm that the multiple bypass openings 114a-c are in the desired position and orientation and that the plug 120 is positioned proximal to the multiple bypass openings 114a-c.

[0038] As described above, the introducer sheath 100 in Figures 1 and 2 is used for delivering medical devices, such as transcutaneous circulation support devices, as will be further explained with reference to Figure 5. Although explained with reference to the transcutaneous circulation support device in Figure 5, the introducer sheath 100 may be used with any variation of the medical device, and the following explanation is provided as an example.

[0039] Figure 5 shows an example of an introducer sheath 100 used in a transcutaneous circulation assist device 130 (also referred to herein as a blood pump 130). Specifically, Figure 5 shows the introducer sheath 100 immediately after the blood pump 130 has emerged from its distal portion 108 and been positioned within a blood vessel V. The blood pump 130 is thus positioned distal to the introducer sheath 100, and the introducer sheath 100 maintains its position within the blood vessel V. The blood pump 130 typically includes an impeller assembly housing 140 and a motor housing 142. In some embodiments, the impeller assembly housing 140 and the motor housing 142 may be constructed as a single unit or monolithically. In other embodiments, the impeller assembly housing 140 and the motor housing 142 may be separate components configured to be removable or permanently coupled.

[0040] The impeller assembly housing 140 houses an impeller assembly 144. The impeller assembly 144 includes an impeller 148 that rotates relative to the impeller assembly housing 140 to deliver blood to the blood pump 130. More specifically, the impeller 148 draws blood from a blood inlet 150 formed on the impeller assembly housing 140, passes through the impeller assembly housing 140, and exits through a blood outlet 152 formed on the impeller assembly housing 140. The inlet 150 may be formed at the end of the impeller assembly housing 140, and the outlet 152 may be formed on the side of the impeller assembly housing 140. In other embodiments, the inlet 150 and / or outlet 152 may be formed on other parts of the impeller assembly housing 140. In some embodiments, the impeller assembly housing 140 is coupled to a distally extending cannula (not shown) that can receive blood and deliver it to the inlet 150.

[0041] Continuing to refer to Figure 5, the motor housing 142 houses a motor 154, which is configured to rotate the impeller 148 relative to the impeller assembly housing 140. In the illustrated embodiment, the motor 154 rotates a drive shaft 156 coupled to a drive magnet 158. As the drive magnet 158 ​​rotates, a driven magnet 160 connected to the impeller assembly housing 140 rotates. In other embodiments, the motor 154 can be coupled to the impeller assembly housing 140 via other components.

[0042] As shown in Figure 5, the catheter 170 extends from the proximal end of the motor housing 142. The catheter 170 typically includes tools such as control wires and, in some cases, guide wires to deliver the medical device to a target location and to allow manipulation of the medical device. These tools can also be used to remove the percutaneous circulatory support device 130 from the patient. The catheter 170 extends outside the patient's body through the introducer sheath 100 and optionally through the plug 120. Figure 5 shows that blood can flow through the introducer sheath 100 through the multiple bypass openings 114a-c, as blood can pass through the percutaneous circulatory support device 130 and enter the distal end 108 of the introducer sheath 100 and exit through the multiple bypass openings 114a-c.

[0043] Figure 6 shows a flowchart disclosing a method 200 for using the introducer sheath 100 shown in Figures 1-3 and 5 in combination with the plug 120 disclosed with reference to Figures 3-4B. In block 202, method 200 includes inserting the introducer sheath 100 into the patient's blood vessel V. This may include inserting the introducer sheath 100 into the patient's incision site so that at least the inner portion 104 extends into the blood vessel V. In block 204, method 200 further includes inserting the percutaneous circulatory support device 130 into the introducer sheath 100. In various embodiments, this includes first introducing the plug 120 into a starter tube, inserting the starter tube into the introducer sheath 100, and then deploying the plug 120 into the introducer sheath 100.

[0044] In block 206, method 200 further includes inserting the plug 120 into the introducer sheath 100. This step may further include inserting the plug 120 so that it is flush with the inner surface of the lumen 112 of the introducer sheath 100 and the outer surface of the catheter or starter tube, so that blood does not pass alongside or inside the plug 120. The plug 120 may be positioned proximal to the most proximal bypass opening 114a of the introducer sheath 100 so as not to obstruct blood flow through each of the multiple bypass openings 114.

[0045] In various embodiments, method 200 further includes removing the plug 120 from the introducer sheath 100, thereby also removing the plug 120 from the introducer sheath 100. As previously described, the introducer sheath 100 has been described in reference to its use with the plug 120, but any type of medical device can be delivered through the introducer sheath 100 as described herein.

[0046] One of the further advantages of the introducer sheath 100 described herein is that it eliminates the need for another repositioning sheath to be incorporated into the system. In other words, the introducer sheath 100 can remain in place for the entire duration that the percutaneous circulatory support device 130 is inside the patient's body. Because there is no need to remove the introducer sheath 100 and place an additional sheath, the occurrence of trauma or stress on the blood vessel V can be reduced.

[0047] Various modifications and additions can be made to the exemplary embodiments described without departing from the scope of the present invention. For example, while the embodiments described above refer to certain features, the scope of the present invention also includes embodiments having different combinations of features, and embodiments that do not include all of the features described above.

Claims

1. An introducer sheath for use in the delivery of transcutaneous circulatory support devices, The hub at the proximal end of the introducer sheath, A proximal portion opposite to the distal portion, and a main body portion extending between the proximal portion and the distal portion, the main body portion defining the lumen of the introducer sheath configured to receive at least one transcutaneous circulatory support device, At least one bypass opening located in the proximal portion of the introducer sheath, the at least one bypass opening extending from the outside of the introducer sheath to the lumen of the introducer sheath, At least one plug disposed within the lumen of the introducer sheath, wherein the at least one plug is located distal to the hub and proximal to the at least one bypass opening, and is configured to restrict blood flow to the lumen proximal to the plug. Introduction series, including.

2. The introducer sheath according to claim 1, wherein the at least one bypass opening includes a plurality of bypass openings located in the proximal portion of the introducer sheath.

3. The introducer sheath according to claim 1, wherein the at least one plug is positioned in a proximal direction to the at least one bypass opening and directly adjacent to the at least one bypass opening.

4. The introducer sheath according to claim 2, wherein the at least one plug is positioned directly adjacent to the nearest bypass opening among the plurality of bypass openings.

5. The introducer sheath according to claim 1, wherein at least one of the plugs is made of silicone.

6. The introducer sheath according to claim 1, wherein at least one of the plugs has a radiopaque coating.

7. The introducer sheath according to claim 1, wherein at least one of the plugs is made of a radiopaque material.

8. The introducer sheath according to claim 1, wherein at least one bypass opening is lined with a radiopaque material.

9. The introducer sheath according to claim 1, wherein the at least one plug has a central opening for a seal engagement with a catheter disposed within the introducer sheath.

10. The introducer sheath according to claim 9, wherein the central opening is composed of a plurality of slits.

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